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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - 00810020440164

For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2353G
In Commercial Distribution

  • 10810020440161 ()
  • 00810020440164 ()
4R2353G

  • Apheresis system tubing set

AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - 00810020440140

For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2354G
In Commercial Distribution

  • 00810020440140 ()
  • 10810020440147 ()
4R2354G

  • Apheresis system tubing set

Aurora Plasmapheresis System Software Version 2.1 - 00810020440003

Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system

Cellfie - 07290110123055

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 07290110123055 ()
AAVF16042301

  • Liposuction system

StemTrol Control Cells - 15099590220020

StemTrol Control Cells
Beckman Coulter, Inc.
IM3632
In Commercial Distribution

  • 15099590220020 ()
IM3632

  • Fixative, Orth's solution

StemComp Reagent - 15099590220013

StemComp Reagent
Beckman Coulter, Inc.
IM3631
In Commercial Distribution

  • 15099590220013 ()
IM3631

  • Fixative, Orth's solution

LeukoTrol - 15099590639402

Leuko-Trol Platelet Control Cells
Beckman Coulter, Inc.
PLT Control
In Commercial Distribution

  • 15099590639402 ()
175651

  • Full blood count IVD, control

LeukoTrol - 15099590639396

Leuko-Trol RBC Control Cells
Beckman Coulter, Inc.
RBC Control
In Commercial Distribution

  • 15099590639396 ()
175658

  • Full blood count IVD, control

StemONE software - 15099590559519

stemONE
Beckman Coulter, Inc.
6915452
In Commercial Distribution

  • 15099590559519 ()
6915452

  • Laboratory instrument/analyser application software IVD

StemTrol Control Cells - 15099590762896

StemTrol Control Cells
Beckman Coulter, Inc.
IM3632US
In Commercial Distribution

  • 15099590762896 ()
IM3632US

  • Fixative, Orth's solution
  • Multiple CD cell marker IVD, control
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